Engineer - Utilities

This position will be part of the Utilities group within Site Support Services and the successful candidate will be System Owner for certain Utility Systems within the group. The Utilities Engineer reports to the Sr. Manager Utilities. The candidate will have knowledge and proficiency in a variety of Utilities areas, including GMP and nGMP Utility systems, the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to systems and equipment and their associated automation systems.

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• Monitoring of day to day performance of their assigned systems.
  
• Measuring and maximizing the uptime of their systems.
  
• Data trend analysis of all performance aspects of their systems and equipment to identify and proactively manage performance trends, including anticipating, solving or escalating problems as appropriate.
  
• Troubleshooting of performance trends.
  
• Risk assessments and mitigation projects relating to system performance.
  
• Ensuring the preventive maintenance schedule for their systems is successfully implemented.
  
• Ensuring that critical spare parts lists for their system are identified and appropriate levels of spares are maintained.
  
• The definition and scoping of all improvement activities relating to the system.
  
• Acting as Site SME for their systems, including hosting audits and inspections by regulatory authorities.
  
• All design reviews associated with equipment purchases / changes to their systems.
  
• All QMTS/Deviation Triage sessions, investigations, NCs and CAPAs associated with their systems, including the ownership and completion of any RCAs.
  
• The development and execution of FAT, SAT and IOQ protocols
  
• Representing Utilities on site based teams involved in implementing new technology, products or business processes to the site.
  
• Reviewing and approval of changes to operating procedures and the change control process relating to their systems.
  
• Owning and completion of any CMMS administrative WOs associated with their systems.
  

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• Bachelors degree in Engineering (Mechanical, Electrical, Chemical).
  
• Experience in the Pharmaceutical or BioTechnology industries, in a direct or supportive Engineering role, operating equipment and troubleshooting all types of Utility systems, including electrical, mechanical and instrument experience, an advantage.
  
• Demonstrated leadership skills with the ability to supervise vendors, build on site teams and operate across functional boundaries, both internal and external. xcfaprz
  
• Significant experience large project related activities including GMP qualification experience.